“Vampire Facelift”- Dr Zdinak featured Expert in New York Times!


‘Vampire Face-Lifts’: Smooth at First Bite


IN this anti-aging age, perhaps it’s unsurprising that vampires — ancient, but with forever-young skin — are a cultural obsession. Now a cosmetic treatment to fill in wrinkles or to plump up hollow cheeks is being marketed as a “vampire filler” or a “vampire face-lift.”

In fact, it’s not surgery, but an in-office procedure that entails having blood drawn from your arm, then spun in a centrifuge to separate out the platelets. They are then injected into your face, with the hope of stimulating new collagen production. Selphyl, as the system is called, arrived on the booming facial-rejuvenation market in 2009, and is now used by roughly 300 doctors nationwide in the name of beauty, said Sanjay Batra, the chief executive of Aesthetic Factors, which manufactures the Selphyl system.

This year, the “vampire face-lift” has been promoted on “The Rachael Ray Show” and “The Doctors.” It’s also gotten air time on more than a dozen local news programs, some of which presented unproved claims that results will last two years.

Dr. Drew Ordon, one of the hosts of “The Doctors” and a board-certified plastic surgeon, gushed on air, “Vampires have moved into plastic surgery, too, and I’m one of them.” The patient in his segment had also recently had her own fat injected into her face to plump it, so it wasn’t clear that platelets had anything to do with her fresher appearance. (Not that that stopped audience applause.)

Ghoulish as the procedure sounds, some patients prefer the idea of using their own blood rather than a neurotoxin or synthetic filler to rejuvenate their faces. “We all want to look better,” said Joan Sarlo, 56, who underwent a Selphyl “vamp-lift” performed by Dr. Lisa A. Zdinak, a Manhattan-based doctor whose specialty is ophthalmic plastic surgery. But the “less unnatural the better,” Ms. Sarlo said. “What could be better than your own blood?”

Some doctors say that fillers taken from one’s body are less likely to cause irregularities and bumps in thin-skinned areas than synthetic ones like Sculptra Aesthetic. But at this point, it’s hard to tell whether “platelet-rich fibrin matrix,” or P.R.F.M. (the medical term for the golden-hued platelets that Selphyl extracts), is an effective filler for hollowed-out cheeks and wrinkles.

Dr. Anthony P. Sclafani, the director of facial plastic surgery at the New York Eye and Ear Infirmary, said he’s seen the revivifying effects of P.R.F.M. on cosmetic patients last for more than a year — sometimes 18 to 24 months. (Dr. Sclafani is a paid consultant for Aesthetic Factors, and most of his research on Selphyl has been financed by the company.)

But no national clinical trial has been done to prove such claims. “There simply isn’t any objective data out there supporting the claim of two years,” Dr. Jeffrey M. Kenkel, a board-certified plastic surgeon and a spokesman for Physicians Coalition for Injectable Safety, wrote in an e-mail.

Dr. Phil Haeck, the president of the American Society of Plastic Surgeons, is troubled by the lack of research proving the efficacy of Selphyl, which costs $900 to $1,500 for a procedure that takes less than a half-hour. “There are no scientific studies, only personal attestations,” he said, adding that he thinks the “creepy” concept is as antiquated as bloodletting to cure disease. “This is another gimmick that people are using to make themselves stand out on the Internet in a real dog-eat-dog part of medicine.”

What’s more, doctors and consumers aren’t clear on where Selphyl stands with the F.D.A. In a YouTube video featuring Dr. John Argerson, a board-certified family medicine doctor who works out of Refine MediSpa in Johnson City, Tenn., tells consumers that Selphyl is a “newly F.D.A.-approved filler” for nose-to-lip folds. And in a December 2009 article in Dermatology Times, a trade publication, Dr. Ranella Hirsch, a board-certified dermatologist, said Selphyl is “a new F.D.A. approved dermal filler.” This week, Dr. Hirsch, who doesn’t use Selphyl in her practice, said that she couldn’t explain why she misspoke, adding in an e-mail that “the lack of clarity between F.D.A. approval versus F.D.A. clearance to market is a key point.”

Indeed. The F.D.A. has not approved or cleared P.R.F.M. derived in a Selphyl centrifuge to be marketed for facial rejuvenation. In 2002, the agency cleared a blood-collection system called Fibrinet, whose platelet-rich byproducts orthopedic doctors then used to speed tissue repair. In 2009, this same machine was born again as Selphyl, and since then, the company promoted it as a way to “reverse the natural aging process.” This week, Shelly Burgess, an F.D.A. spokeswoman, said that Selphyl’s maker would have to file an amendment to get clearance to market its blood collection system in a new way, and no such amendment could be found at this writing.

Asked whether Aesthetic Factors’ marketing of Selphyl for cosmetic rejuvenation violated any F.D.A. policy, Ms. Burgess simply wrote, “As a regulatory agency we would not discuss whether a firm’s claims violate our regulations.”

Dr. Anthony Youn, a board-certified plastic surgeon who introduced the vampire face-lift to viewers of “Rachael Ray” this year, admitted in an interview, “There’s very little data behind Selphyl” and that he’s injected just a half dozen patients with P.R.F.M. “Patients tolerate it beautifully, but I haven’t seen any dramatic results yet,” said Dr. Youn, based in Troy, Mich.

Dr. Sclafani, who has injected roughly 150 patients, wrote in an e-mail that Selphyl can correct early signs of aging like crow’s feet, loss of facial volume and under-eye hollows “in a progressive, natural way and rejuvenate a person’s appearance in a subtle but distinct way.”

Dr. Joseph M. Gryskiewicz, the chairman of the emerging trends committee for the American Society of Plastic Surgeons, said he was impressed by Dr. Sclafani’s before and after photos, some taken with appropriate lag time to test longevity. “They look as good as any filler out there,” he wrote in an e-mail. Dr. Gryskiewicz, a board-certified plastic surgeon in Edina, Minn., who doesn’t offer the “vampire filler,” doesn’t feel P.R.F.M. derived from Selphyl can be compared with Botox, because, he wrote, “one fills a space, the other inhibits muscle action.” But he sees the point of using Selphyl’s P.R.F.M. as a volumizer, considering the alternatives. “Lots of patients are freaked out about the lumps with Sculptra, and lots of patients don’t want to do surgery that is fat transfer, but they want their hollow cheeks fixed.”

Last week, a retrospective no-placebo study of 50 of Dr. Sclafani’s patients injected with their own platelet-rich fibrin matrix one to five times and then assessed on average 9.9 months later was published online in the Archives of Facial Plastic Surgery. It didn’t prove that P.R.F.M. is an effective filler, but Dr. Kenneth R. Beer, a dermatologist in West Palm Beach, Fla., said it did suggest that it was generally safe to use to treat nasiolabial folds or sunken cheeks. That said, Dr. Beer, who is a paid consultant and investigator for Medicis and Allergan, the makers of Restylane and Juvéderm respectively, wrote of Selphyl in an e-mail: “The major risk, in my estimation, will be from people that don’t understand the anatomy or the procedure injecting this into veins or arteries.”

Since last March, Dr. Ali Vafa, a board-certified internist who now injects fillers at New York Medical Aesthetics in SoHo, has offered Selphyl to patients afraid to use Botox or synthetic injectables — thus far about 35, some in conjunction with other fillers. But there isn’t a lot of “good clinical research behind” the procedure, he said. “You sort of go by what other doctors have seen who have been doing it for a period of time.”

Ann, a 39-year-old preschool teacher from Brooklyn who wanted to use only her first name for privacy’s sake, had her hollow cheeks treated by Dr. Vafa last August. “As part of the aging process, all our faces will thin out,” Ann said. She saw a gradual improvement after Selphyl, and liked that she didn’t have any palpable bumps as she had after using Perlane, a hyaluronic acid filler approved by the F.D.A.

“When they come to me, I don’t promise it will improve everything,” said Dr. Vafa, who charges $1,000 to $1,200 to inject P.R.F.M. “I say it’s for prevention, it will improve skin quality and volume.” He calls the procedure a “vampire face-lift” on one of his Web sites, though with some squeamishness about its sensationalism..

But Dr. Charles Runels, a cosmetic doctor in Fairhope, Ala., liked the term so much he trademarked it. Dr. Runels, who used to be a board-certified internist, said this was to standardize the offering so patients know what to expect. His vampire face-lift entails first volumizing the face with Juvéderm, a hyaluronic acid filler that lasts up to a year, then “using Selphyl to polish off under the eyes, and thinner-skin areas,” he said.

Now any doctors who want to promote the vampire face-lift must pay Dr. Runels $47 a month to follow his protocol, posted online. (So far, 10 have signed up.) Asked what he intends to do about all the doctors already using vampire face-lifts, he said, “I don’t know how I’m going to rein it back in but I will.” Maybe Dracula could help.

Stay Beautiful!!

Dr. Lisa


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